Idea Transcript
FACULTAD DE CIENCIAS DE LA SALUD DEPARTAMENTO DE PSICOLOGÍA BÁSICA, CLÍNICA Y PSICOBIOLOGÍA
NUEVOS ABORDAJES PARA EL TRATAMIENTO DE LA FIBROMIALGIA: UNA INTERVENCIÓN POSITIVA PARA LA PROMOCIÓN DEL OPTIMISMO MEDIANTE LA UTILIZACIÓN DE TICs
TESIS DOCTORAL
Presentada por: Guadalupe Molinari
Dirigida por: Dra. Cristina Botella Arbona Dra. Azucena García-Palacios Castellón, Abril 2017
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Índice
CAPÍTULO I
Introducción General
5
CAPÍTULO II
Development and pilot testing of a positive imagery intervention with online support in the treatment of fibromyalgia
27
CAPÍTULO III
The power of visualization: back to the future for pain management in fibromyalgia syndrome
63
CAPÍTULO IV
How and for whom does a positive affect intervention work for fibromyalgia: An analysis of mediators and moderators
108
CAPÍTULO V
Validación de instrumentos de medida utilizados en el estudio empírico
145
Psychometric properties of the General Self
Efficacy-12
scale
in
Spanish:
general and clinical population samples
3
The contribution of future directed thinking
to
affect
168
dimensions:
differences in general and clinical populations Assessment of positive affect regulation:
198
validation of the Spanish version of the Response
to
Positive
Affect
questionnaire in clinical and general samples
CAPÍTULO VI
Discusión General Referencias Bibliográficas Anexos
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239 261 274
I.
Introducción general La fibromialgia (FM) es una enfermedad de etiología desconocida que
se caracteriza por la presencia de dolor crónico generalizado acompañada de una gran variedad de síntomas somáticos, afectivos y cognitivos. Entre ellos, destacan la fatiga persistente, el sueño no reparador, la rigidez generalizada, los problemas de concentración y memoria, y los síntomas ansiosodepresivos (Rivera y cols., 2006). La prevalencia mundial de la FM está estimada en un 2,7% y varía de acuerdo al país de estudio. En España, su prevalencia en población general se sitúa en un 2,4% (Queiroz, 2013). Por sexos, la prevalencia entre los varones se estima en un 0,2%, frente a un 4,2% en las mujeres, lo que supone una relación mujer:varón de 21:1. Según el estudio EPIFFAC realizado en España, el 84% de los pacientes con FM tienen una o más enfermedades comórbidas: un 67% tienen otras afecciones musculoesqueléticas, un 35% sufre de trastornos psicológicos, un 27% de trastornos gastrointestinales, un 23,5% de trastornos cardiovasculares y un 19% de trastornos endocrinológicos (Castells y cols., 2013). Si bien esta enfermedad ha adquirido notoriedad en los últimos años, cuenta con 110 años de historia, y desde sus comienzos la FM se ha considerado una enfermedad controversial. La ausencia de patología orgánica específica demostrable, la gran heterogeneidad de síntomas (muchas veces compartidos con otros síndromes de dolor crónico) y el debate en torno a su especificidad diagnóstica, han ocasionado numerosos cuestionamientos a su reconocimiento como enfermedad y al establecimiento de sus criterios diagnósticos. Es por ello que aún hoy continúan en revisión
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(Wolfe y cols., 2011). Estas controversias han repercutido en el diagnóstico, evaluación y abordaje terapéutico de la FM. En el período comprendido entre 1990 y 2010 las investigaciones científicas se dispararon, centrándose en el estudio de los mecanismos neurobiológicos de la FM, encontrando cada vez más un mayor número de síntomas asociados a la FM y diagnósticos comórbidos con otros síndromes como la fatiga crónica o el síndrome de colon irritable. Las evidencias de que se trataba de un síndrome que generaba un gran impacto psicosocial en la vida de las personas y que muchas de ellas presentaban además trastornos mentales asociados eran cada vez mayores.
1. Más allá del modelo biopsicosocial del dolor La complejidad de la fibromialgia ocasiona que se recomiende que su abordaje sea también
integral. En este sentido, los modelos bio-psico-
sociales del dolor son ampliamente aceptados (Flor y Turk, 2011). Éstos sostienen que para comprender la percepción y la respuesta de la persona al síndrome de dolor debemos tener en cuenta la interrelación entre factors biológicos, su estado psicológico y el contexto sociocultural en el que se encuentra (Gatchel, Peng, Peters, Fuchs y Turk, 2007). De esta manera, la experiencia de dolor es el resultado de la transmisión y modulación de la información sensitiva. Y este proceso será diferente para cada individuo, teniendo en cuenta su disposición genética, su historia de aprendizaje, su estado psicológico y su contexto sociocultural (ver Figura 1).
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Figura 1. Modelo de los procesos biopsicosociales involucrados en la salud y enfermedad. Figura adaptada de Gatchel (2004)
Actualmente, se han propuesto nuevos modelos para entender los procesos involucrados en el fenómeno del dolor crónico (Jensen, Tan y Chua, 2015; Jensen, Ehde y Day, 2016). Esta propuesta se basa en el modelo de dos sistemas neurofisiológicos, de castigo y recompensa, de Jeffrey Gray (1990). De acuerdo a este modelo, el primer factor (BAS) es un sistema responsable de las conductas de acercamiento, y sus emociones (ej. Esperanza, alegría, entusiasmo) y cogniciones asociadas (ej. Autoeficacia). El segundo factor (BIS), por el contrario, es el sistema responsable de las conductas de evitación o inhibición, y sus emociones (ej. Ansiedad, depresión) y cogniciones asociadas (ej. Desesperanza). Estos dos sistemas se activan cuando, dentro de las condiciones ambientales, existe alguna señal de recompensa o castigo. Las señales de recompensa activarían el sistema BAS, mientras que las señales de castigo harían lo propio con el sistema BIS. En el caso del dolor, al tratarse de una experiencia aversiva para el individuo,
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activaría el sistema BIS, lo que generaría conductas como la inactividad o la interrupción de actividades que, a su vez, se asociarían a cogniciones negativas, como la catastrofización del dolor, y a emociones negativas como el miedo y la ansiedad. La experiencia de dolor, a su vez, podría tener un efecto indirecto (y negativo) en el sistema BAS, ocasionando un abandono de metas vitales y una inhibición de las respuestas cognitivas y emocionales positivas (Jensen, Ehde y Day, 2016). A diferencia de los modelos biopsicosociales del dolor que hipotetizan una relación causal y muchas veces unidireccional entre los distintos factores, estos nuevos modelos de conceptualización del dolor crónico proponen relaciones de causalidad mutua, con factores que interaccionan y provocan cambios en otros, sin que ninguno de estos factores o sistemas sea el central (ver Figura 2).
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Figura 2. Modelo del BIS y BAS en dolor crónico. Figura adaptada de Jensen, Ehde y Day (2016)
En este sentido, desde un punto de vista clínico, los comportamientos, cogniciones y emociones asociadas al dolor son entendidos tanto como mecanismos de acción, así como resultados o consecuencias del dolor. Esto permite ampliar la mirada, no sólo a la hora de conceptualizar la experiencia de dolor, sino también en el abordaje terapéutico del mismo. Por ejemplo, hasta hace algunos años, los ensayos clínicos de dolor incluían medidas de sintomatología depresiva o ansiosa únicamente como medidas de resultados (Morley, Eccleston y Williams, 1999; Scascighini, Toma, Dober-Spielmann y Sprott, 2008). Sin embargo, siguiendo estos modelos, las emociones pueden entenderse también como agentes capaces de influenciar las conductas y los
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pensamientos asociados al dolor. Y en este punto, no sólo las emociones negativas, sino también las emociones positivas (Fredrickson, 2001).
2.
Más allá de las emociones negativas: importancia de los factores protectores En los últimos años, gracias a estas nuevas conceptualizaciones acerca
de la experiencia de dolor, se ha empezado a estudiar la importancia de los factores protectores en pacientes con dolor crónico (Sturgeon y Zautra, 2010, 2013). Los factores psicológicos positivos como la aceptación del dolor, las emociones positivas y las estrategias adaptativas de afrontamiento influyen en el curso y en la experiencia de dolor. El afecto positivo actúa amortiguando la experiencia de dolor a través de la reducción de la catastrofización del dolor (Hood, Pulvers, Carrillo, Merchant y Thomas, 2012) y ampliando el foco de atención y cognición hacia estímulos y experiencias no dolorosas (Finlan y Garland, 2015). Estudios recientes han encontrado una correlación negativa entre medidas de afecto positivo e intensidad del dolor en pacientes con FM (Finan, Zautra, Davis, 2009) y otros síndromes de dolor crónico (Tooyserkani, Besharat, Koochi, 2011; Zautra, Johnson y Davis, 2005). Asimismo, el afecto positivo se asocia a menores niveles de afecto negativo, especialmente en momentos de dolor intenso, y a menores niveles de depresión (Davis, Zautra y Smith, 2004; Strand y cols. 2006). Aunque son aún escasos, algunos estudios han explorado el rol del afecto positivo como moderador en la relación entre el dolor y algunos síntomas asociados. Thong, Tan y Jensen (2017) encontraron que aquellos participantes que tenían bajos niveles de 10
afecto positivo evidenciaban correlaciones significativas entre la intensidad del dolor, el afecto negativo y niveles de depresión; mientras que aquellos participantes que manifestaban niveles elevados de afecto positivo, no mostraron correlaciones significativas entre dichas variables. Esto quiere decir que el afecto positivo parece actuar como “protector” frente al impacto del dolor. Esta relación entre los niveles de afecto positivo y dolor parece variar en función del diagnóstico (Finan y Garland, 2015). Se ha demostrado que los pacientes con FM reportan mayor dolor y estrés diario que los pacientes con osteoatritis, y estas diferencias son explicadas por los niveles de afecto positivo. Además, los pacientes con FM presentan niveles de afecto positivo significativamente menores que los de pacientes con otras enfermedades reumatológicas (Zautra y cols., 2005). Estos déficits en el funcionamiento del afecto positivo en la FM también se han observado en estudios controlados de laboratorio mediante inducciones a través de imágenes positivas (Kamping, Bomba, Kanske, Diesch y Flor, 2013). Otro de los factores protectores que se ha estudiado en relación al dolor crónico es el optimismo. El optimismo es entendido como una orientación hacia el futuro que se asocia a expectativas de resultados positivas (Carver, Scheier, Segerstrom, 2010). Si bien el optimismo es considerado un rasgo disposicional estable, muchos estudios sostienen la posibilidad de modificarlo en la edad adulta (Segerstrom, 2007). El optimismo ha sido relacionado con una menor sensibilidad al dolor, un mejor funcionamiento físico, una mayor adaptación al dolor y una reducción del malestar psicológico (Goodin y cols., 2013). Se ha demostrado que los 11
individuos más optimistas son menos propensos a percibir las barreras que obstaculizan el camino hacia sus objetivos y, en los días que sienten más fatiga, son menos propensos a reducir su esfuerzo para alcanzar los mismos (Affleck y cols., 2001). La percepción de autoeficacia en el manejo del dolor y sus consecuencias se ha caracterizado como un recurso psicológico protector y un factor de resiliencia asociado con la mejora de la función física en pacientes con dolor crónico (Edwards, Dworkin, Sullivan, Turk y Wasan, 2016). En un reciente meta-análisis, niveles bajos de autoeficacia en estos pacientes se asociaron a mayor incapacidad funcional, a un mayor número de problemas emocionales y mayor severidad del dolor (Jackson, Wang, Wang y Fan, 2014). En síntesis, si bien la evidencia científica ha demostrado que los factores protectores positivos generan una serie de beneficios para los pacientes con dolor crónico, no existen en la actualidad prácticas empíricamente validadas que apunten directamente a aumentar los niveles de estas variables positivas. Por esta razón, es necesario el desarrollo y puesta a prueba de intervenciones que promuevan estos factores protectores que parecen resultar claves en la autogestión del dolor. Además, es necesario promover modelos que ayuden a entender cómo y para quiénes funcionarían estas intervenciones.
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3.
Nuevos abordajes terapéuticos para el tratamiento de la fibromialgia Como hemos señalado, la experiencia de dolor de estos pacientes es
compleja e incluye factores conductuales, cognitivos y afectivos que afectan la calidad de vida de aquellos que la padecen. Por esta razón, los enfoques psicológicos han centrado sus esfuerzos en reducir la incapacidad generada por el dolor, el malestar emocional, y las estrategias de afrontamiento desadaptativas, más que buscar una reducción directa del dolor (Roditi y Robinson 2011). Las terapias cognitivo-comportamentales, la relajación, las intervenciones psicoeducativas, los tratamientos conductuales y los programas basados en mindfulness han demostrado ser efectivos en reducir los problemas de sueño, la depresión, el estado funcional y la catastrofización de los pacientes (Glombiewski y cols., 2010). Sin embargo, la evidencia de décadas de ensayos clínicos demuestra que los tamaños de efecto son modestos y sugiere que gran parte de la varianza de los resultados en los estudios sobre el tratamiento del dolor, y variables relacionadas con el dolor, sigue sin ser abordada en los tratamientos disponibles (Morley, Williams y Eccleston, 2013). Normalmente, los enfoques terapéuticos son presentados a los pacientes dentro de un objetivo general orientado a disminuir las consecuencias negativas del dolor (Finan y Garland, 2015). Sin embargo, recientemente se han aplicado nuevas intervenciones clínicas para el manejo del dolor dirigidas a cambiar el enfoque de algunos paradigmas y a mejorar la eficacia de los tratamientos:
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(1) de aliviar y disminuir la manifestación de síntomas negativos a promover recursos de afrontamiento positivos para el dolor (Keefe y Wren, 2013). (2) de las prácticas de salud tradicionales (ej. Terapia cara a cara ) a la inclusión de recursos de salud a través de las tecnologías de la información y de la comunicación (TICs) y de Internet. En cuanto al primer punto, en el campo del dolor, el cambio de enfoque hacia el desarrollo de programas de tratamiento que promuevan factores positivos se hace evidente en los resultados de una reciente revisión sistemática de intervenciones psicológicas positivas en síndromes de dolor crónico (Iddon, Dickson y Unwin, 2016). En este trabajo se analizan 8 estudios (2 estudios cualitativos y 6 estudios cuantitativos) de los cuales todos excepto uno se desarrollaron a partir del año 2014. Esto indica la naturaleza emergente de esta área de investigación. En general, los estudios demuestran que estas intervenciones pueden ser beneficiosas en personas que sufren de dolor crónico, promoviendo mejoras en variables como el bienestar psicológico, la esperanza, auto-eficacia, felicidad y satisfacción con la vida. Las intervenciones psicológicas utilizadas así como los tamaños de efecto encontrados varían de acuerdo a los estudios, aunque suelen ser tamaños de efecto moderados. En cuanto al mantenimiento de los cambios a largo plazo, los resultados son mixtos (Simm, Iddon y Barker, 2014; Flink, Smeets, Bergbom y Peters, 2015; Muller y cols., 2016). Es importante tener en cuenta también que la mayoría de estos estudios no incluyeron un grupo control, y por lo tanto sus resultados deben analizarse con precaución.
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En cuanto al segundo punto, nuevas estrategias de intervención como los tratamientos basados en la evidencia aplicados a través de Internet, el uso de la realidad virtual y de aplicaciones para teléfonos inteligentes en los tratamientos son cada vez más frecuentes (Keogh, Rosser y Eccleston, 2010). Estas tecnologías ofrecen múltiples ventajas: reducen barreras para el acceso a servicios de salud, incrementan la eficiencia de los tratamientos y promueven el autocuidado (Mohr, Burns, Schueller, Clarke y Klinkman, 2013), un aspecto clave a tener en cuenta en condiciones crónicas. En pacientes con FM, la realidad virtual se ha utilizado cómo técnica de exposición frente al temor al movimiento y ha demostrado su eficacia para disminuir la catastrofización hacia el dolor (Morris, Louw, Grimmer y Meintjes, 2015). Asimismo, la realidad virtual se ha utilizado como una técnica adjunta a la terapia cognitivo comportamental para inducir relajación y promover la práctica del minfulness consiguiendo buenos resultados en la reducción del dolor, de la sintomatología depresiva y en la promoción de técnicas de afrontamiento más adaptativas (Botella y cols., 2013). Además, la realidad virtual se ha utilizado para la promoción de emociones positivas y motivación relacionada con actividades significativas (García-Palacios y cols., 2014). Es decir que las TICs también pueden ayudar a promover el funcionamiento positivo, mejorar el bienestar y fomentar la resiliencia en los invididuos. Cuando son utilizadas con este fin, se ha propuesto sean consideradas como Tecnologías Positivas (Botella, Baños y Guillén, 2017; Botella y cols., 2012; Riva, Baños, Botella, Mantovani y Gaggioli, 2016). Aunque las actuales orientaciones en el manejo del dolor tienen como objetivo incorporar las TICs en la asistencia sanitaria y promover los factores 15
protectores contra la experiencia del dolor, hasta la fecha, la investigación combinando estos esfuerzos en pacientes con dolor crónico es limitada (García-Palacios y cols., 2014, Herrero, García-Palacios, Castilla, Molinari y Botella, 2014).
4. Mi Mejor Yo Posible: una propuesta de intervención Hasta hace poco, los efectos beneficiosos del optimismo sobre el dolor habían
sido
estudiados,
fundamentalmente,
a
través
de
estudios
correlacionales y de laboratorio (Goodin y Bulls, 2013). Sin embargo, para demostrar que los factores psicológicos positivos afectan de manera directa al dolor se necesitan estudios experimentales que incluyan intervenciones dirigidas a promover un funcionamiento positivo en pacientes que sufren de dolor. Una de las intervenciones que más se ha utilizado con este propósito es Mi Mejor Yo Posible (King, 2001; Peters, Flink, Boersma, Linton, 2010). Esta intervención consiste en un ejercicio de escritura y visualización con el objetivo de que los participantes imaginen la mejor manera posible en que su vida se podría desarrollar en un futuro, teniendo en cuenta distintos ámbitos de vida: personal, profesional y social. Esta intervención ha sido utilizada en más de 30 estudios que han demostrado su eficacia para promover optimismo, aumentar el afecto positivo y el bienestar psicológico (Loveday, Lovell y Jones, 2016). Ha sido administrada a muestras diversas, incluyendo estudiantes, adultos, pacientes depresivos y pacientes con ideación suicida. Se ha mostrado eficaz al ser aplicada tanto de manera tradicional como
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online y los datos indican que repetir el ejercicio que se propone en la intervención podría aumentar su eficacia. En el campo del dolor, la mayoría de los estudios que han utilizado esta intervención ha realizado ensayos experimentales controlados en entornos de laboratorio con procedimientos de inducción de dolor en participantes sanos (Hanssen, Peters, Vlaeyen, Meevissen y Vancleef, 2013; Hausmann, Parks, Youk y Kwoh, 2014, Boselie, Vancleef, Smeets y Peters, 2014). El ejercicio de Mi Mejor Yo Posible se ha mostrado eficaz para provocar un aumento en el optimismo que, a su vez, redujo la intensidad del dolor durante una tarea de inducción de dolor por frío (Hanssen y cols., 2013). Se ha demostrado que el optimismo elimina las dificultades inducidas por el dolor durante tareas ejecutivas (Boselie y cols., 2014). Además, las imágenes mentales han mostrado ser eficaces para el control del dolor en distintos grupos de personas con dolor crónico (Lewandowski, 2004) y en pacientes con FM (Fors, Sexton y Gotestam, 2002). Específicamente, las imágenes positivas han demostrado ser analgésicas ante el dolor (Alden, Dale y DeGood, 2001). Las imágenes mentales activan los sistemas cerebrales involucrados en el procesamiento de la información emocional, es por esto que las consecuencias emocionales son más potentes que ante la representación verbal de los eventos (Holmes y Matthews, 2005). La realización de ejercicios de visualización positiva tiene efectos sobre las creencias, las emociones y los comportamientos: puede aumentar la probabilidad percibida de que algo ocurra, prepararnos mejor para la acción al imaginar antes nuestros comportamientos, y aumentar el optimismo y expectativas positivas futuras (Holmes y Matthews, 2010). 17
Uno de los primeros estudios en analizar la eficacia de un programa de intervención que incluía el ejercicio de Mi Mejor Yo Posible en pacientes clínicos con dolor crónico fue el trabajo de Flink y cols. (2015). En este estudio, cinco pacientes con dolor lumbar realizaron un tratamiento que incluía diversos ejercicios para promover factores positivos como la gratitud, el saboreo y el optimismo. Los resultados mostraron que tres de los cinco pacientes mostraron mejoras en la incapacidad causada por el dolor y en catastrofización hacia el dolor. No se observaron cambios significativos en las medidas de optimismo, pero se observó una tendencia de mejora en variables de bienestar psicológico. Sin embargo, no es posible analizar el efecto diferencial de cada uno de los ejercicios aplicados, así como los mecanismos de cambio de los mismos. En el mayor estudio realizado hasta la fecha, aplicando intervenciones positivas en pacientes con dolor crónico, Muller y cols. (2016) aleatorizaron a 96 pacientes con diversas condiciones médicas (ej. Esclerosis múltiple, lesión de médula espinal, etc.) a dos grupos experimentales. A los participantes del grupo
intervención
se
les
asignaron
cuatro
actividades
positivas
personalizadas, entre las cuales se encontraban: Actos de bondad, Saboreo, Gratitud, Florecimiento, Optimismo (Mi Mejor Yo Posible), Apoyo Social y Perdón. Los participantes en el grupo control fueron instruidos a ser más atentos a su entorno y escribir sobre tres eventos específicos o actividades que hayan realizado en los últimos 7 días. Los participantes que recibieron la intervención positiva mostraron mejoras significativas en la intensidad e interferencia del dolor, en catastrofización hacia el dolor, depresión, satsifacción con la vida y afecto positivo. Si bien muchos de estos cambios se 18
encontraron también en el grupo control, hubo diferencias significativas en intensidad del dolor en favor del grupo intervención. Muchos de estos efectos positivos se mantuvieron a los dos meses y medio después del tratamiento. Pero nuevamente en este estudio no es posible aislar los efectos específicos de cada uno de los ejercicios aplicados ni los mecanismos de acción de los mismos.
5. Presentación de la tesis doctoral Teniendo en consideración la complejidad de la experiencia de dolor, la eficacia moderada de las intervenciones psicológicas aplicadas hasta el momento para el tratamiento del dolor crónico y la ausencia de evidencia científica acerca de los posibles mecanismos que permitan explicar cómo funcionan estas intervenciones, parece necesario un cambio de paradigma en el tratamiento del dolor (Morley y cols., 2013). Con la inclusión de las intervenciones que promueven variables positivas en los protocolos de tratamiento se ha dado un primer paso en el desarrollo de un enfoque terapéutico dirigido a promover factores psicológicos protectores y así aumentar la eficacia de los tratamientos psicológicos. Sin embargo, los ejercicios psicológicos positivos específicos no han sido aislados y sometidos a prueba de forma específica en pacientes con dolor crónico (Finan y Garland, 2015). La gran mayoría de estas intervenciones han sido diseñadas y validadas en población general, y luego aplicadas en población clínica. Asimismo, a menudo éstas se presentan a los pacientes dentro de un enfoque dirigido a minimizar los aspectos negativos del dolor, o incluidas dentro de "paquetes de tratamiento" que incluyen 19
varios componentes (Flink y cols., 2015, Muller y cols., 2016), por lo que es difícil analizar el papel específico que juegan las intervenciones dirigidas exclusivamente a promover aspectos positivos. Además, la relación causal entre variables psicológicas positivas, como el afecto positivo y el optimismo, y el dolor, así como los mecanismos subyacentes a esta relación, permanecen en gran medida sin respuesta. Por lo expuesto anteriormente, es necesario contar con intervenciones psicológicas específicas, que vinculen cambios psicológicos determinados a variables de resultado particulares (Morley y cols., 2013). En vista de la importancia de contar con herramientas terapéuticas que puedan facilitar el manejo del dolor en pacientes con FM, y teniendo en consideración los alentadores resultados que se han obtenido hasta el momento mediante la incorporación de las TICs para aumentar la eficiencia de las intervenciones psicológicas en este grupo de pacientes (GarcíaPalacios y cols., 2014; Morris y cols., 2015), el objetivo de esta tesis doctoral ha sido desarrollar, implementar y someter a prueba la eficacia de una intervención psicológica apoyada en las TICs, orientada a la promoción del optimismo y del afecto positivo en pacientes con FM. Esta tesis se plantea por tanto, abordar las cuestiones pendientes relativas al rol de las variables psicológicas positivas como factores protectores frente al dolor y en la promoción del bienestar en la experiencia de dolor. Específicamente, esta tesis tiene como objetivo responder a dos preguntas centrales de investigación: "¿Una intervención psicológica, exclusivamente basada en la promoción del afecto positivo y apoyada en TICs, es eficaz en la reducción del malestar sintomático y en la promoción del 20
bienestar?". Y "¿Cuáles son los mecanismos subyacentes a la eficacia de esta intervención?: ¿cómo y para quién funciona?". Con este propósito, se han realizado tres estudios principales: el primero es un estudio piloto centrado en el desarrollo y adaptación de la intervención psicológica orientada a promover emociones positivas (Mi Mejor Yo Posible) mediante el uso de TICs, y el análisis de su eficacia preliminar en una serie de casos clínicos de pacientes que sufren de FM; el segundo, analiza la eficacia de esta intervención psicológica que utiliza TICs y que incluye promoción de optimismo y afecto positivo, en un estudio controlado aleatorizado en pacientes que sufren de FM; en el tercer estudio, se analizan los moderadores y mediadores de la eficacia de esta intervención. Asimismo, se han realizado tres estudios complementarios que consisten en la validación al español de instrumentos de medida utilizados en la evaluación de las medidas de resultados principales vinculadas a la intervención. Este trabajo se enmarca en una de las líneas de investigación que viene desarrollando desde hace varios años el grupo de investigación de la Dra. Botella, la Dra. García-Palacios y la Dra. Baños, de la Universidad Jaume I de Castellón y de la Universidad de Valencia, orientada a la aplicación de TICs (Realidad Virtual, Realidad Aumentada, Internet, dispositivos móviles, etc.) en el campo de la Psicología Clínica en general, así como en el área de la Psicología de la Salud en particular (por ejemplo, Botella et al., 2013; Herrero y cols., 2014, García-Palacios y cols., 2014). La presente tesis doctoral adquiere un formato por compendio de publicaciones, incluyendo artículos indexados en reconocidas revistas de 21
impacto y publicaciones científicas internacionales. En el momento de la redacción de esta tesis dos artículos estaban publicados y otros cuatro trabajos habían sido enviados a revistas de relevancia científica para su revisión y posterior aceptación. La tesis doctoral que se presenta se compone de cuatro capítulos que recogen cada uno de los artículos mencionados (Tabla 1). Aunque todos los capítulos están orientados al objetivo principal, cada uno de ellos cuenta con entidad propia, pudiendo ser leídos de manera independiente. Los coautores han manifestado su aceptación para que el doctorando presente el trabajo como tesis así como su renuncia expresa de presentarlo como parte de otra tesis doctoral. De acuerdo con la normativa de estudios de doctorado regulados por el RD 99/2011 (que modifica el Real Decreto 1393/2007 de 29 de Octubre al que se inscribe la presente tesis doctoral) en la Universitat Jaume I, para las modalidades de Doctorado por compendio de publicaciones, los artículos científicos que dan cuerpo a esta tesis han sido redactados en lengua inglesa siendo el idioma habitual de comunicación científica. Han sido redactados en castellano la introducción general y la discusión general.
Tabla 1. Estudios científicos de la presente tesis doctoral Capítulo II
Development and pilot testing of a positive imagery intervention with online support in the treatment of fibromyalgia
Capítulo III
The power of visualization: back to the future for pain management in fibromyalgia syndrome
Capítulo IV
How and for whom does a positive affect intervention work for fibromyalgia: An analysis of mediators and moderators 22
Capítulo V
Psychometric properties of the General Self Efficacy-12 scale in Spanish: general and clinical population samples The contribution of future directed thinking to affect dimensions: differences in general and clinical populations Assessment of positive affect regulation: validation of the Spanish version of the Response to Positive Affect questionnaire in clinical and general samples
6. Objetivos e hipótesis de la tesis doctoral El objetivo general de la presente tesis doctoral es diseñar, implementar y evaluar la eficacia y efectividad (aceptabilidad) de una intervención psicológica centrada en la promoción de emociones positivas que utiliza TICs y que se dirige a la promoción del bienestar psicológico en pacientes que sufren de fibromialgia.
En concreto, los objetivos específicos que se persiguen son: Diseñar y aplicar una intervención psicológica que utiliza TICs y que se dirige a la promoción del bienestar psicológico en pacientes que sufren de fibromialgia (Mi Mejor Yo).
Explorar la utilidad de dicha intervención para inducir optimismo y afecto positivo en un grupo de pacientes con fibromialgia en un estudio piloto.
Aportar datos acerca de la eficiencia (aceptación, utilidad percibida, viabilidad) de la intervención psicológica implementada (Mi Mejor Yo)
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Evaluar la eficacia de la intervención en medidas de bienestar psicológico a corto (pre-post) y a largo plazo (seguimientos) en un ensayo clínico controlado en el que se compara la eficacia de Mi mejor Yo con la eficacia de una intervención control.
Evaluar posibles moderadores y mediadores acerca de la eficacia de una intervención para promover optimismo y afecto positivo en pacientes con fibromialgia (Mi Mejor Yo).
Para la consecución de estos objetivos se han llevado a a cabo dos estudios empíricos, un estudio piloto y un ensayo clínico controlado.
Las hipótesis a contrastar en el estudio piloto son las siguientes:
Relacionadas con la utilidad de la intervención: H1: Después de que los pacientes completen un mes de práctica de la intervención (Mi Mejor Yo) apoyada en TICs para inducir estados de ánimo positivos, se observará un aumento significativo en las emociones positivas y una disminución en las emociones negativas, así como un aumento en las expectativas de futuro positivas y una disminución de las negativas.
H2: Una vez finalizado el programa de intervención de Mi Mejor Yo, se observará un incremento significativo respecto a las puntuaciones preintervención en las medidas de optimismo y calidad de vida, así como una
24
disminución en la sintomatología depresiva, las medidas de catastrofización, y estado emocional negativo.
H3: Los resultados obtenidos se mantendrán en los seguimientos realizados al mes y a los 3 meses.
Relacionadas con la aceptación de la intervención: H4: Los pacientes otorgarán puntuaciones elevadas en aceptación y satisfacción con la intervención de Mi Mejor Yo y el uso de las TICs (utilidad, lógica, recomendación a terceros, agrado).
Las hipótesis a contrastar en el estudio controlado fueron las siguientes:
Relacionadas con la eficacia de la intervención de Mi Mejor Yo: H1: Después de una sesión en la que los pacientes realicen la intervención de Mi Mejor Yo apoyada en TICs para inducir estados de ánimo positivos, se observará un aumento significativo en las emociones positivas y una disminución en las emociones negativas, así como un aumento en las expectativas de futuro positivas y una disminución de las negativas, y este cambio será significativamente mayor en el grupo intervención en comparación con el grupo control.
H2: Una vez finalizado el programa de intervención, se observará un incremento significativamente mayor respecto a las puntuaciones preintervención en las medidas de optimismo, afecto positivo, auto-eficacia y 25
calidad de vida, así como una disminución en la sintomatología depresiva, las medidas de catastrofización, y afecto negativo, en la condición que reciba la intervención de Mi Mejor Yo en comparación con la condición control.
H3: Los resultados obtenidos en la condición de intervención de Mi Mejor Yo se mantendrán en los seguimientos realizados al mes y a los 3 meses, siendo este mantenimiento de los logros significativamente superior que en la condición control.
Relacionadas con los mecanismos subyacentes a la intervención: H5: Los cambios del pre al post-intervención en afecto positivo y negativo, mediarán los efectos de la intervención de Mi Mejor Yo en la interferencia del dolor, los niveles de depresión, los niveles de autoeficacia y calidad de vida.
H6: Los cambios del pre al post-intervención en sintomatología depresiva mediarán los efectos de la intervención de Mi Mejor Yo en la interferencia del dolor, los niveles de autoeficacia y calidad de vida.
H7: Los niveles iniciales de variables de resultado (interferencia del dolor, afecto, autoeficacia y calidad de vida), así como de las variables de proceso (estrategias de regulación emocional y rumiación), moderarán los efectos de la intervención de Mi Mejor Yo sobre los niveles de depresión.
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II. Development and pilot testing of a positive imagery intervention with online support in the treatment of fibromyalgia Este capítulo ha sido aceptado para su publicación en la Revista Argentina de Clínica Psicológica. Autores: Molinari, G., Enrique, A., Herrero, R., FernándezLlanio Comella, N., Botella, C., y García-Palacios, A. (2017).
Abstract Positive psychology interventions (PPI) represent a promising method to promote resources to better cope with pain. This study aims to describe the rationale for a PPI for fibromyalgia and outline a potential model by which a positive imagery exercise supported by Information and Communication technologies could lead to resilience in chronic pain. We present preliminary data of acceptability and feasibility of the Best Possible Self intervention with online support for clinical patients. In general, larger effect sizes and clinically significant change were found on measures of functional status and depression. An increment in quality of life was observed. This is the first study to provide preliminary evidence for the efficacy of a PPI in fibromyalgia using technologies to enhance self-management. Keywords:
Fibromyalgia; Positive psychology intervention; Best Possible
Self; Pain resilience; Information and Communication technologies
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Introduction If there is one syndrome that challenges diagnosis, treatment and prognosis is fibromyalgia syndrome (FMS). Heterogeneity in history, symptoms expression, comorbidity and treatment response have caused that in 30 years of research no pharmacological or nonpharmacological treatment has proven to be effective for all patients (Okifuji and Hare 2013). FMS is a chronic musculoskeletal pain condition with unknown etiology, characterized by widespread pain, accompanied by fatigue, function disability, disturbed sleep, and affective disorders. In sum, pain experience in these patients is complex and involves behavioral, cognitive and affective factors that cause an impaired quality of life. For that reason, psychological approaches have concentrated their efforts in reducing pain-related disability, emotional distress, and maladaptative coping, rather than directly eliminating the locus of pain (Roditi and Robinson 2011). Cognitive behavioral therapies, relaxation, educational interventions, behavioral treatments, and mindfulness based programs, have proved to be effective in reducing sleep problems, depression, functional status and catastrophizing (Glombiewski et al. 2010). Therapeutic approaches are typically presented to patients within the general theme of minimizing negative appraisals of pain (Finan and Garland 2014). However, recently novel clinical interventions have been applied to pain management aiming to shift paradigms: (1) from alleviating and decreasing symptoms manifestations to promoting resources for coping with pain (Keefe and Wren 2013) and (2) from routine face to face health care practices, to the addition of e-health resources and information and communication technologies (ICTs), such as 29
evidence based online interventions, virtual reality, and smartphone applications (Keogh et al. 2010). These technologies offer multiple advantages: reducing barriers to access health care andincreasing treatment efficiency and promoting self-management (Mohr et al. 2013), a core aspect in chronic conditions. Positive psychological factors such as pain acceptance, positive emotions, and adaptative coping strategies, influence the course and experience of pain. Positive affect serve as a buffer to pain through the reduction in pain catastrophizing (Hood et al. 2012) and broadening the scope of attention and cognition to nonpainful stimuli and experiences (Finlan and Garland 2014).
Optimism has been linked to lower pain
sensitivity, better physical functioning and adjustment to pain, and less psychological distress and pain catastrophizing (Goodin et al. 2013). Until recently, the beneficial effects of optimism on pain have been studied mostly in correlational studies in clinical and laboratory settings (Goodin and Bulls 2013). To demonstrate that positive psychological factors causally affect pain, experimental studies that include direct interventions are needed. Interventions aimed to promote positive psychological constructs have been developed in the positive psychology field. These positive psychology interventions (PPI) have proved to be effective in reducing depression and promoting subjective and psychological wellbeing (Sin and Lyubomirsky 2009). However, evidence from a recent meta-analysis shows that a substantial number of studies (17 of 39) have been tested in college students (Bolier et al. 2013). Moreover, in the field of pain, most of these interventions have been developed in controlled experimental lab research 30
with pain inductions procedures (Hanssen et al. 2013; Boselie et al. 2014) or healthy participants (Hausmann et al. 2014), and have not been replicated in clinical populations. For a PPI to be effective in increasing wellbeing is important not only the characteristics of the exercise but also the features of the person, known as person-activity fit (Lyubomirsky and Layous 2013). For that reason, we believe the positive psychology field is lacking of interventions specifically adapt and design for clinical populations. The aim of this study is to describe the adaptation and utilization of a PPI intervention, the Best Possible Self, with fibromyalgia patients. For this reason, we propose how a PPI could be combined with ICTs to provide a successful intervention for clinical patients. We describe a system developed by our team that includes narratives, sounds, and visual cues to focus patients’ attention on the task and to potentiate the effects of the guided imagery exercise. Moreover, we present preliminary results of the intervention study with the Best Possible Self manipulation in a long term basis. To improve adherence, we gave patients access to a web-based platform and provide support through text messages twice a week. The level of acceptance and perceived utility as well as possible benefits of this intervention were also examined.
Method Intervention rationale and development Health psychology has benefited from positive psychology (Aspinwall and Tedeschi 2010). Moreover, recent models have been proposed to conceptualize how positive psychology constructs, such as positive affect and 31
optimism, operate in the adaptation and self-management of chronic pain (Finan and Garland 2014). Taking into account this model, our aim was to develop an intervention for fibromyalgia patients with the intention to promote protective positive psychology factors to cope with pain. For this reason, we reviewed the PPI literature, including recent meta-analyses (Sin and Lyubomirsky 2009; Bolier et al. 2013), to identify validated exercises that target positive variables (e.g. hope, optimism, positive affect) that have been consistenly found to be related with pain. Some of the conclussions of this review were that: (i) most of the interventions were addressed to college students or general population; (ii) individuals with psychosocial problems and who expected the intervention to make them happier benefited more from PPI´s; (iii) in terms of design of the intervention, individual therapy was most effective, longer interventions were more likely to produce greater gains in wellbeing and have higher effect sizes, as well as studies involving referrals from a health care practitioner. Although these results are encouraging, most of these studies have small or medium effect sizes, and share a common barrier: adherence. We consider PPI´s as a first step into the development of a tailored therapeutic approach aimed to promote protective psychological factors. In this sense, specific positive psychology elements have not been extracted and tested in chronic pain patients (Finan and Garland 2014). Empirically supported psychosocial treatments often include interventions to enhance health but they are presented to patients as an approach directed to minimize negative appraisals of pain or in a “treatment package” (Flink et al.
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2015; Muller et al. 2016) that include several exercises, so it´s difficult to analyze the specific role of PPI´s. For that reason, we propose a model (see Figure 1) by wich a PPI may lead to greater resilience in chronic pain. We selected an intervention to promote optimism considering that previous studies have demonstrated the beneficial effects of optimism in improving pain-related symptoms (e.g. lower pain sensitivity and less psychological distress). We chose a simple, well— accepted and applicable intervention: the Best Possible Self (BPS) (Peters et al. 2010). It consists of a writing and guided imagery exercise that promotes positive future thinking by asking the patient to think about the best possible way that his life could turn out in 3 life domains: personal, relational, and professional. The BPS, compared to control, significantly increased optimism and positive affect in general population after a 2 weeks intervention (Meevissen et al. 2011). In the field of pain, the BPS has demonstrated that increasing optimism is effective in reducing pain intensity ratings during a cold pressor task (Hanssen et al. 2013). Moreover, it has proved that optimism abolishes pain-induced impairments in executive task performance (Boselie et al. 2014). Mental imagery has shown its efficacy for pain control in diverse chronic pain populations (Lewandowski 2004), and in fibromyalgia patients (Fors et al. 2002). Specifically, positive imagery has demonstrated greater pain analgesia (Alden et al. 2001). Mental imagery activates brain systems involved in processing emotional information therefore it has more powerful emotional consequences than does the verbal representation of events (Holmes and Matthews 2005, 2010). Deliberate engagement in positive future imagery has effects on beliefs, emotions and behaviors: it can 33
enhanced the perceived likelihood of an event, increase optimism and positive future expectancies, and increase readiness for action of an imagined behavior. For fibromyalgia patients, this can be specially significant considering they report significantly lower positive affect than other rheumatology diseases (Zautra et al. 2005) and it has been demonstrated that more optimistic individuals were less likely to perceive goal barriers and, on days that they experienced more fatigue, they were less likely to reduce their effort in achieving their goals (Affleck et al. 2001). Once the exercise was selected, we aimed to customize and adapt the BPS intervention to clinical patients. In terms of the design of a self-applied PPI, it was important not only to focus on efficacy but also in adherence. In this sense, ICTs offer the advantage of easy accessibility, personalized materials to enhance engagement and virtual support to promote motivation. We performed qualitative interviews with psychologists who are specialize in e-health interventions to define support duration and personalization, delivery method, design of the positive technology system to deliver the exercise and the online platform to access the material to practice the exercise.
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Figure 1. Model of the mechanisms and methods by which the Best Possible Self intervention could promote resilience and pain self-management
In terms of content of the BPS manual, we followed Meeviseen et al. (2011) instructions, with the exception that we included a health domain, specially relevant for this population. Due to the fact that longer interventions seem to produce greater gains in wellbeing and that the BPS manipulation has only been tested in a short term biasis, we included two follow-ups, at one month and at three months after completion of the intervention.
Intervention supported by ICTs Patients were informed that they were participating in a study in order to measure “the power of visualization”. Patients were asked to think of and write down all aspects that their future best possible self should 35
encompass in personal, social, professional and health domains. To do so, patients used an interactive system called the Book of Life (see Figure 2a) (Baños et al. 2014). This system consists of a personal diary to promote positive narrative and a positive orientation towards the future. Moreover, multimedia resources (music, pictures, and videos) could be included to boost imagery. Patients were given 25 minutes to complete the exercise and 5 more minutes to visualize what they have just wrote. All patients were instructed to repeat the imagery exercise once a day at home over the next four weeks. In order to facilitate the practice, patients received access to an online platform called Emotional Therapy Online (TEO; Quero et al.2012). TEO is a completely open web-based system that allows the creation of personalized therapeutic material. Patients can access this material over the Internet using a personal password and visualize their personal diary with the narrative and multimedia they had selected at the lab session. At the end of the session, they can move around a virtual environment (they can choose a beach or a forest environment) to think about the session and their experience and continue visualizing their BPS (see Figure 2b). Finally, twice a week, SMS were sent to the patient’s mobile phone with reminders to practice their exercise and reinforcements.
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Figure 2. The Book of Life and TEO systems for the realization of the BPS manipulation.
Participants Ten patients were referred by a rheumatologist from the Rheumatology Unit of Hospital Arnau of Vilanova. After the screening interviews, 7 patients were accepted into the study, and further assessments were conducted. All participants consented to this research protocol as approved by the Ethical committee at the University Jaume I. Measures Fibromyalgia Impact Questionnaire (FIQ-R; Esteve-Vives et al. 2007). The FIQR is a 10-item self-report questionnaire that measures the health status of patients with FMS assessing the interference of FMS in their daily life. The total score of the FIQ-R is calculated by adding 4 items. The first item focuses on the patient’s ability to perform physical activities. The following two items require the patient to indicate the number of days in the past week they felt good and how many days of work he or she missed. The remaining item is 37
composed by seven questions assessing the interference of pain to perform daily activities and other symptoms (pain, fatigue, morning tiredness, stiffness, anxiety, and depression) that are measured with a numerical rating scale (NRS). Psychological distress was assessed by the Spanish version of the Brief Symptom Inventory (BSI; Ruipérez et al. 2001). Depression. The Spanish version of the Beck Depression Inventory (BDI-II; Sanz et al.2005) is a 21-item self-report measure of cognitive, affective and somatic symptoms of depression. It is one of the most frequently used measures of depression in chronic pain patients. Its threshold for detecting depression varied according to the type of patients, suggesting the need for adjusting cut-off points to 22 to reduce the number of false-positives produced by the uneven item response of chronic pain patients (Poole et al. 2006). Therefore, we used this value as our cut-off. Pain Catastrophizing. In the Pain Catastrohpizing Scale (PCS; Campayo et al. 2008) patient is ask to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales from (0) not at all to (4) all the time. The PCS yields a total score and three subscale scores assessing rumination, magnification and helplessness. For the purpose of this study, we used the PCS total score. Optimism and Future expectancies – The Life Orientation Test-revised (LOT-R; Otero et al. 1998) includes 10 items that assesses dispositional optimism. The Subjective Probability Task (SPT; MacLeod 1996, Molinari et al. in press) was used as a measure of positive (10 items) and negative (20 items) future 38
expectancies. The SPT consists of 30 items scored on a 7-point Likert scale ranging from 1 (not at all likely to occur) to 7 (extremely likely to occur). The Positive and Negative Affect Scale (PANAS; Sandin et al.1999) includes 20item evaluating positive and negative affect. Quality of life. The Spanish version of the Quality of Life Index (QLI-Sp; Mezzich et al. 2000) consists of 10 items evaluating different dimensions of psychological well-being. Acceptance and perceived usefulness. We used a satisfaction and acceptability scale (Borkovec and Nau 1972) to measure satisfaction with the BPS manipulation after completion of the intervention. The participants rated the items on a 0 to 10 scale where 0 was “not at all” and 10 was “completely.” Also, patients were asked to rate the satisfaction and usefulness of each of the systems used, the frequency of applying the imagery exercise (number of sessions per week) and content of imagery. Procedure The rheumathologist of local public hospital gave general information about the studies and referred FMS patients interested in participating. All participants attended voluntarily and received no incentive. Patients had to fulfill the American College of Rheumatology criteria for primary FMS (Wolfe et al. 1990) and not present a severe psychiatric condition. Once the participants gave written informed consent to participate, a brief structured interview was conducted in order to assess pain history and treatments. Patients were assessed at baseline with the BSI. Patients took home the rest of the assessment protocol that had to be completed for the following lab session. In the following session, patients received a BPS manual and listened 39
to the instructions through headphones to guarantee standardization and facilitate concentration (Meevissen et al. 2011). Next, the researcher presented to the patient the Book of life system and explained how to use it. After 25 min of writing about their BPS and selecting their images, music and videos, they performed the 5-min imagery exercise. Patients were told that they would receive an email giving them access to TEO to practice their exercise at home. The post intervention session took place at the university in the fourth week. The FIQ-R, measures of pain catastrophizing, anxiety and depression, positive and negative affect, future expectancies, optimism and quality of life, were administered. An interview was conducted in order to assess frequency of applying the imagery exercise and the acceptance and perceived utility of the intervention. At last, patients were asked to continue practicing their exercise and they were informed that they were going to be contacted at1 and 3 month follow-ups. At follow-ups, patients completed the same questionnaires that at post intervention, except for the FIQ-R.
Results Baseline characteristics The seven patients were all women, had a mean age of 45 years old (range=24-60, SD=11) and a mean disease duration of 9.8 years (SD=3.25). See Table 1 for each patient demographics and pain history.
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Table 1. Demographic characteristics Age
Marital
Education
Status FIB1
46
Separated
High
Employme
Previous
nt
treatment
Unemployed
Yes
school
Medication
Pain History
Anxiolitics
She has been suffering pain from the last 12 years. “It
Antidepressants
was hard to live with pain, until I discover my
(SSRI)
condition had a name”. Now she feels some days she can cope with her pain, and some days she can´t.
FIB2
49
Married
University degree
Active
No
No
She has been suffering pain from the last 7 years. She received her diagnosis 3 years ago. She doesn´t like
worker
her job and feels she has no purpose in life. FIB3
48
Married
High
Unemployed
No
No
She has been suffering pain from the last 7 years. “My doctors, friends and family think my pain doesn´t
school
exist”. She´s worried about the future. FIB4
60
Separated
High
Unemployed
Yes
Anxiolytics
She has been suffering pain from the last 10 years since menopause. Pain makes it difficult to perform
school
daily activities and it makes her feel “unconnected” to her life and family.
41
FIB5
48
Married
High
Active
school
worker
No
Anxiolytics
She has been suffering pain from the last 15 years. It started on her leg and now it´s worst on her knees. She got her FM diagnosis two months ago. She feels misunderstood by her doctors.
FIB6
24
Single
University
Student
Yes
Anxiolytics
degree
She has been suffering pain from the last 6 years since a car accident She has back pain and problems sleeping wich has increased in the last year. She feels isolated and misunderstood. “I´m only 24, how can I continue with my life?”
FIB7
40
Married
University degree
Active
Yes
Antidepressants
worker
(SSRI)
She have had pain problems all of her life, but received the FM diagnosis 8 years ago. Most of the time she feels without energy to do things she would like to do.
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At baseline, all the patients had a severe impairment caused by fibromyalgia symptoms (FIQ-R Total Score≥ 59). In terms of psychological distress and symptomatology, scores on the General Disability Index showed a great psychological discomfort (M=53.28; SD=18.06) compared to normative data (Ruiperez et al. 2001).
Outcome data Figures 3, 4 and 5 describe each client’s raw data for outcomes at baseline, post-intervention, and 1 and 3-month follow-up assessments. In order to assess the clinical significance of the change resulted from the intervention, Clinical Significant Change (CSC) was calculated using Jacobson and Truax's Reliable Change Index (RCI, 1991). In the “c” criterion, the posttest score has to be closer to the mean distribution of the functional population rather than the dysfunctional. When data was not available for functional population, we chose “a” criterion to decide when a patient had achieved a clinically significant improvement: the posttest score had to be two standard deviations in the direction of functionality above the mean for a dysfunctional population. Then we calculated the RCI to analyze the second condition to test the CSC, where an RCI equal to or greater than |1.96| (p ˂ .05) indicates a reliable change. To calculate the RCI, we used the posttest mean and the pretest mean of the result achieved for each patient, and the mean dysfunctional, the standard deviation and the stability reliability. We used data from the measures in chronic pain patients or in samples with mood disorders when it was not available. 43
Figure 3. Raw data for each patient at pre, post, and follow-ups. Note. FIQ-R: Fibromyalgia Impact Questionnaire, PCS-TOTAL: Pain catastrohpizing scale, BDI-II: Beck Depression Inventory, OASIS: Overall Anxiety Severity and Impairment Scale. a* Clinically significant change. It is used the criterion A of the Jacobson and Truax´s index (1991).
c*
Clinically significant change . It is
use the criterion C of the Jacobson and Truax's index (1991).
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Figure 4. Raw data for each patient at pre, post, and follow-ups. Note. QLI: Quality of Life Index, LOT-R: Life Orientation Test.
c*
Clinically significant
change. It is use the criterion C of the Jacobson and Truax's index (1991).
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Figure 5. Raw data for each patient at pre, post, and follow-ups. Note. PANAS NEG: Negative affect schedule, PANAS POS: Positive affect schedule, SPT NEG: Negative expectations, SPT POS: Positive expectations. c* Clinically significant change . It is use the criterion C of the Jacobson and Truax's index (1991).
46
The scores for the FIQ-R, showed a reduction from pre to post intervention in 5 of the 7 patients. Four of them achieved a reliable change according to the RCI. Scores in pain catastrophizing decreased at postintervention in 6 of the 7 patients. The most important result is that patients continued to improve in the follow-up period, achieving a higher reduction in negative thoughts and feelings associated with pain. Changes in this variable were reliable changes according to the RCI in patients 1, 3, and 4. There was a reduction in depression from pre to post-intervention in 5 of the 7 patients. Four of them achieved a reliable change. The decrease was more prominent in participants who scored above the scale’s cutoff score for chronic pain: participants 3 and 4. But also one of the patients with the lowest score at pretest had a drop of 9 points in the BDI-II at post intervention. One of the patients presented an increment on BDI scores that was a reliable change. However, only one of the patients scored above 22 at the 1 month follow-up and none of the patients had significant levels of depression at the 3 months follow-up. Results indicated an increase in positive affect for 4 of the 7 patients at post intervention However, in only 2 of the patients these scores continued to increase from post intervention to follow-up and were reliable changes. Negative affect was reduced from pre to post-intervention in 4 of the 7 patients, and these results were maintained in the follow-up. Patients 3, 4 and 6 scored reliable changes. Future expectancies showed mix results. On one hand, 4 of the 7 patients presented an increase in positive future expectancies at postintervention. Unexpectedly, patient 5 showed a reliable decrease in positive 47
expectancies during the whole intervention. Only 3 patients achieved a reliable change in positive expectancies. On the other hand, 4 patients presented a score reduction in negative future expectancies at postintervention. One of the patients showed a significant increment in negative expectancies at post intervention but this was not maintain at follow-ups. At the 3-months follow-up, 3 of the patients showed a reduction of almost 20 points regarding their baseline level and achieved reliable changes. Results for the LOT-R showed no change for almost all of the patients, with the exception of patients 3 and 5 that achieved a reliable change according to the RCI. Patient 5 (who had had the lowest score in this measure) achieved an important increase in optimism at the 3 months follow-up. In terms of quality of life, 3 of the 7 patients improved from the pre to post-intervention. One of the patients showed a significant decrease in quality of life at post intervention but this was not maintain at follow-ups. Patients 3 and 4 duplicated their scores in this measure at follow-ups achieving a reliable change. Table 2 describes the means, standard deviations, and effect sizes (Cohen 1988) from pre- to post-intervention, pre-intervention to 1 month follow up and pre-intervention to 3-months follow-up for each outcome.
48
Table 2. Effect sizes (d) of outcomes Pre
Post
Follow up 1 M Follow up 3
Pre
M (SD)
M (SD)
(SD)
intervention d
FIQ-R
69.3 (4.39)
59.32 (16.07)
PCS Total
25 (11.11)
18.57 (9.29)
18 (11.39)
13.17 (10.93)
BDI-II
17.29 (5.94)
11.28 (5.68)
13.71 (7.11)
OASIS
6 (3.41)
5 (3.74)
PANAS Pos
25.43 (4.65)
PANAS Neg
M (SD)
to
Post Pre to Follow- Pre to Followup 1 d
up 3 d
0.50
0.55
0.90
14.5 (6.94)
0.88
0.52
0.40
6.71 (5.5)
5.5 (4.37)
0.25
-0.18
0.12
29 (6.19)
25.17 (8.47)
27.5 (11.04)
-0.68
0.04
-0.38
22.86 (5.24)
19.71 (5.56)
18.5 (5.96)
16.5 (5.68)
0.52
0.70
1.02
SPT Pos
48.71 (8.32)
50.14 (11.77)
44.5 (11.22)
47 (12.5)
-0.15
0.43
0.17
SPT Neg
60.43
49.86 (17.39)
44 (17.94)
55.16 (9.60)
0.61
0.91
0.29
1.98
(15.13) LOT-R
14 (6.24)
15.28 (7.41)
14 (7.64)
18.17 (5.42)
-0.18
0.0
-0.57
QLI
5.21 (1.46)
5.70 (1)
6.46 (1.75)
6.15 (0.94)
-0.29
-0.73
-0.54
Note. Effect size (d) calculation from Cohen (1988) d=0.2 are regarded as a ‘‘small’’ effect size, d=0.5 as ‘‘medium,’ and d=0.8 as ‘‘large”. For the means and effect sizes, sample size at pre-treatment, post-treatment and 1 month follow-up was 7, with the exception of positive and negative emotions (PANAS) and future expectancies (SPT) which had data for 6 patients. At the 3 months follow-up, data was available for 6 patient
49
During the intervention, patients practiced the imagery exercise from 1 to 4-5 times a week. At follow ups, in general, patients decreased the frequency of applying the exercise. Only one of them increased her practice. Patients expressed a high degree of satisfaction with the intervention and a very positive opinion of it´s utility (see Table 3). Its average ratings for each question are shown in Table 4.
Table 3. Participant´s opinions about the intervention Participants
Opinions
FIB1
"During the exercise, I felt like pain was put it in a drawer. I found it pleasant. It's a pain patch. The pain remains but these days I'm taking it in a different manner”.
FIB2
“What I liked the most was that it forced me to take time for myself and ask me what were my goals and how could I make them a reality. But sometimes I was tired and it was exhausting to do it. I think anyone could benefit from this exercise, it´s not necessary to suffer from FM. We all suffer “low seasons” and I think these exercises help you”.
FIB3
“You think in something beautiful, something that you like. It relaxes you. I think that any person that needs to improve both physically and mentally could benefit from this exercise”.
FIB4
“I have visualized myself being able to walk, meeting new people that brought positive things to my life. I think it helped me to feel better and let my mind rule over my body. I think it would be nice if you could share your exercise with other people. When I couldn´t use my computer, I did it on my mobile phone”.
FIB5
“I thought in accessible goals, like improving the relationship with my daughter and the progress of my store. It helps your mind to overcome problems and pain. Medications don´t do that. I liked that it forced me to dedicate time to think in these things, which I normally don´t do”.
FIB6
“I visualized how I want and hope my future will be: finishing school, finding a job, being stable. I liked thinking that I could achieve those goals, because I see them distant and difficult.
FIB7
“I imagined myself more relaxed, I thought in being a good mother to my children and that it´s okay to make mistakes. The exercise forces you to think positively about yourself, something that I never do. It makes you to face you fears. At first, I was afraid to fail, to get stuck in the past. I think it would be good to do it in groups and with a therapist to lead the way”. 50
Table 4. Utility and satisfaction with the intervention
M(SD) To what extent were you satisfied with the
6.71 (2.29)
imagery exercise you received? To what extent would you recommend this imagery exercise to a friend who has the
6.86 (2.61)
same problem? To what extent do you think the imagery
6.57 (1.81)
exercise has been helpful? To what extent have you found this imagery exercise aversive?
1.71 (2.98) Satisfaction
Utility
M (SD)
M (SD)
The Book of Life
7 (1.73)
7.57 (1.9)
Emotional Therapy Online
8.5 (1.0)
8.75 (1.5)
7.86 (2.67)
8 (2.82)
Manual
7 (1.83)
7.57 (1.81)
Images
6.86 (1.95)
7.29 (2.29)
Audio quality
7.43 (1.9)
7.57 (1.9)
Videos
7.50 (2.07)
7.67 (2.06)
Positive Technologies
SMS messages
Note. Patients rated the items on a 0 to 10 scale where 0 was “not at all” and 10 was “completely.”
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Discussion The aim of this study was to present a PPI intervention designed for clinical patients and preliminary test its efficacy in FMS patients. To our knowledge, it is the first study to test the BPS manipulation in FMS patients and using the benefits of technology to enhance intervention adherence and self-management. Our results showed that the BPS imagery exercise led to a significant decreasedepression and impact of pain in functional status in fibromyalgia patients. For the FIQ-R, a change of 14% has been considered clinically relevant (Bennett et al. 2009). Patients achieved a reduction in the impairment caused by FM symptoms, showing changes in FIQ-R total scores ranged from 1.39% to 41%., and 4 of the 7 patients achieved a reliable change. Reduction in depression scores were significant at post intervention and effect sizes were large. At the 3 months follow-up, none of the patients had a clinically significant level of depression. Pain catastrophizing showed a significant reduction at post-intervention but, moreover, it continued to disminish progressively until the 3 months follow-up. However, when employing the RCI only 3 of the patients showed a reliable change. Our results are in line with previous studies that experimentally induced pain and optimism, and found a reduction in situational and dimensional pain catastrophing in healthy participants (Boselie et al. 2014; Hanssen et al. 2013). Moreover, we extended previous findings by demonstrating that a BPS manipulation can have an effect on pain catastrophizing in chronic pain patients that have been suffering pain for approximately 10 years. These results are in line with previous studies reporting changes from 10% up to 52
43% (Jensen et al. 2001; Adams et al. 2007) in catastrophizing following psychological interventions. Our results showed that at the 3 months followup, patients presented a reduction from 22% up to 98% in PCS. Regarding future expectancies, we found a significant reduction in negative expectancies at post-intervention that was maintained at follow-up. Four of the patients presented a reduction of 20 points in their baseline scores at the 3 months follow-up. Patients reported less negative affect from pre-intervention to post-intervention. The most relevant finding is that patients continued to improve in the follow-up, achieving a higher reduction in negative emotions, with large effect sizes. In terms of positive affect, patients reported more positive emotions although these results were not maintain at follow ups for most of the patients. Surprisingly, we found an increase in positive future expectancies that was reliable according to the RCI in only one of the patients. Taking into account previous BPS studies that, on the contrary, did not find any effect of induced optimism on negative affect (Sheldon and Lyubomirsky 2006; Peters et al. 2010; Meevissen et al. 2011), we found a significant effect on negative future expectancies and negative affect, but not in positive future expectancies and positive affect. It should be noticed that previous studies were perfomed on healthy subjects and these results could be explained due to differences in populations. Further studies in clinical samples should clarify these differences. Dispositional optimism showed no significant change at post intervention and at 1 month follow-up. Only one of the patients achieved a reliable change. However, at the 3 months follow-up results demonstrated an increase in LOT-R scores, in patient FIB5 who had a change of 20 points with 53
respect to her baseline levels. These results are in line with a recent study analyzing the nature of optimism (Eichner et al. 2014) and concluding that due to the dimensional characteristic of its structure, interventions aimed at increasing optimism should expect to gradually increment a more flexible and optimistic thinking. Another aspect worth mentioning is the fact that most of the studies using the BPS manipulation assumed changes in optimism, while actually they do not include the LOT-R as an outcome variable. One exception is the study by Flink et al. that include the LOT-R in a positive intervention protocol that incorporated the BPS. However, this study did not find changes in this measure at post intervention. Researchers that expect to apply positive psychology interventions (PPI) in a short term basis should consider the inclusion of different scales to examine optimism and include a long term design, specially for clinical populations. One of the key aspects of PPI is to promote well-being. Our results showed that patients that practiced their BPS imagery exercise reported an increased in their quality of life at post-intervention that was maintained at follow-ups. Another aspect worth highlighting is the patients’ acceptance of the use of technologies. Participants agreed that the use of The Book of Life helped them to visualize their exercise, and they considered TEO useful in practicing their exercise at home. In particular, they appreciated the SMS messages, which made it easier to remember to do the practice. Our study has some limitations that should be considered. First, this is a pilot study and because of that we used a small and convenient sample. A more representative sample of FMS patients would allow the generalization of our findings. Another concern refers to our effect sizes. Although we found 54
effect sizes that would be consider large by standars (Cohen 1988), because of the sample size, results should be interpreted with caution. Moreover, when employing a more strict methodological measure of change results where modest. Also, we did not include the FIQ-R at follow-ups, and it should be included in future studies in order to assess changes on health status and impact of FMS in a long term basis. We believe our study makes an important contribution not only to PPI research but also to pain research, helping to understand how a PPI works in a special population, fibromyalgia patients, expanding its efficacy data in clinical populations and adding knowledge to the role that positive psychological factors have in pain experience. Also, our results add information of a good way to implement the BPS exercise integrating technologies into an existing healthcare delivery system. This initial pilot study encourages us to continue exploring the use of technology-based guided imagery interventions with this population and to conduct a randomized clinical trial to test its efficacy comparing to a control intervention. We think that management of this chronic pain condition needs to tailor multi-component interventions for the individual patient, taking into account new clinical interventions that address positive resources (Goodin and Bulls 2013), and understanding that if it is a chronic condition, selfmanagement is eventually a must.
55
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III. The power of visualization: back to the future for pain management in fibromyalgia syndrome Este capítulo ha sido enviado para su publicación a la revista Pain Medicine. Autores: Molinari, G., García-Palacios, A., Enrique, A., Roca P., FernándezLlanio Comella, N., y Botella, C. (submitted).
Abstract Objective: Previous studies have demonstrated the effects of positive psychological factors on pain adjustment. Specifically, optimism has been linked to better physical functioning and less psychological distress. Until recently, these beneficial effects have mostly been examined in correlational studies or laboratory settings. The aim of this study is to test the efficacy of the Best Possible Self intervention using information and communication technologies with fibromyalgia patients. Methods: Seventy-one patients were randomly allocated to the Best Possible Self intervention or a Daily Activities control condition. The Best Possible Self intervention used an interactive multimedia system with the support of an Internet platform to practice the guided imagery exercise online. Results: Intent-to-treat analyses showed that, compared to the control condition, Best Possible Self patients showed significant improvements in depression, positive affect, and self-efficacy at post-intervention. Moreover, at 3-month follow-up, patients that received the intervention improved their
63
optimism and negative affect significantly more than control condition participants. Discussion: This study shows how a technology-supported intervention aimed at augmenting positive affect and promoting positive functioning works in the case of fibromyalgia, expanding the intervention’s efficacy data in clinical populations and adding knowledge about the role that positive psychological factors play in pain experience. Moreover, it demonstrates the specific effects of the Best Possible Self intervention in order to incorporate this exercise in pain treatment protocols.
Keywords: fibromyalgia, treatment outcome, optimism, best possible self, selfefficacy
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Introduction Fibromyalgia syndrome (FMS) is a chronic widespread pain condition characterized by fatigue, functional disability, disturbed sleep, cognitive impairment, and mood disorders [1]. Due to the heterogeneity in the presentation and severity of symptoms among patients, to date, no psychological or pharmacological treatment has been found to be effective for all patients. FMS patients take more medication, make six more yearly medical visits, and show a higher average of work days missed than the reference population [2]. FMS affects up to 3% of the population, and these data suggest annual incremental costs of up to approximately €12 billion for a population of 80 million for every year these patients are not treated [3]. FMS patients experience significantly low levels of quality of life that remain stable over time, even compared to other chronic pain disorders [4]. Comorbid depression is very common among FMS patients, with a lifetime prevalence of 62-86% [5], often accompanied by cognitive dysfunctions and pain catastrophizing, which lead to avoidance and withdrawal from daily life activities [6]. Approximately 35% of patients report difficulties in performing common everyday activities [7]. In sum, pain experience in FMS is complex and multidimensional. Therefore, established guidelines recommend a multi-component approach [8]. Treatment options include pharmacotherapy (evidence-based treatment guidelines recommend four drug classes: anti-epileptic drugs, tricyclic antidepressants, selective serotonin reuptake inhibitors, and serotoninnorepinephrine reuptake inhibitors [9]; as well as aerobic exercise, relaxation, acupuncture, massage therapy, and psychological treatments. 65
Psychological approaches comprise behavioral interventions, such as activity pacing or graded exposure to movement, combined with cognitive components (e.g. cognitive restructuring, problem-solving, and coping skills) [10, 11, 12] and the use of mindfulness strategies and acceptance and commitment therapy skills [13]. These approaches have commonly focused on reducing negative emotions, cognitions, and maladaptive coping associated with pain [14]. Although psychological approaches have traditionally concentrated on reducing negative symptoms associated with pain, new developments in pain management emphasize the role of positive affect and positive adjustment factors in coping with pain (for a review, see [15]). In this regard, some empirically supported psychosocial treatments have included interventions to enhance positive factors, but they are presented to patients as an approach designed to minimize negative appraisals of pain or as part of a “treatment package” [16, 17, 18] that includes several exercises. Therefore, the specific role of positive psychology interventions is difficult to analyze. There is considerable variation in the combinations of treatment strategies across trials, and most of them report small to moderate effect sizes in reducing pain-related disability, emotional distress, and maladaptive coping [19]. However, in order to improve their efficacy and accessibility, a change in the design and implementation of pain treatments is needed [20]. In terms of theoretically-driven treatment models, treatment protocols combine several components, but with little evidence about merits of one combination of components over another or the rationale for including specific components [12]. Most of these treatment components have shown 66
their efficacy in broader fields of research, but they have not been individually tested in people with chronic pain [21]. In this study, we focus on testing a single component designed to enhance positive affect and positive adjustment. In the implementation of pain treatments, an important aspect is to promote self-management [22]. To do so, face to face applications could benefit from the integration of technologies to enhance self-management and extend the reach and feasibility of psychological interventions for chronic pain [23]. Recent meta-analyses and research studies provide evidence for the efficacy of Internet-based interventions [24, 25], virtual reality [26, 27, 28], and smartphone applications [29] in managing pain. These technologies reduce barriers to accessing health care, while decreasing costs, increasing treatment efficiency, and promoting self-management [30], a core aspect of chronic conditions. Technologies can also help to promote positive functioning, improve wellness, and foster strength and resilience in individuals. They are referred to as Positive Technologies [31, 32, 33]. Although current directions in pain management aim to incorporate ICTs in healthcare and promote protective factors against experiencing pain, to date, research combining these efforts in chronic pain patients is limited. Moreover, to our knowledge no study has tested a single positive intervention in a chronic pain population to analyze its isolated effect. For these reasons, we adapted a positive future-thinking intervention using Information and Communication Technologies (ICTs) [34], the Best Possible Self (BPS), which combines positive imagery with goal setting in different self-domains. An ICT-based computerized system [35, 36] 67
(Emotional Activities Related to Health, EARTH) supported by a web-based online platform [37] (Emotional Therapy Online, TEO) with a brief automated short message service (SMS) was developed to provide therapist support and encourage exercise practice in fibromyalgia patients. The aim of this study is to extend the findings of the pilot study and test the efficacy of the BPS intervention in fibromyalgia patients compared to an active control condition. To our knowledge, this is the first controlled study to test this intervention in fibromyalgia patients. Taking into account previous results that demonstrated the efficacy of this intervention in general population [38, 39] and experimentally-induced pain [40, 41] samples, the first hypothesis is that FMS patients will present lower levels of negative expectations and negative affect and higher levels of positive affect and positive future expectations after a single session of the BPS intervention. The second and main hypothesis is that patients in the BPS condition will present lower levels of depression and negative affect and higher levels of positive affect and positive future expectations after the one month intervention, compared to patients in the daily activities condition. The third hypothesis is that patients in the BPS condition will report lower levels of pain catastrophizing and negative future expectations and higher levels of self-efficacy and quality of life, compared to patients in the control condition after the one month intervention. Finally, because there is a lack of empirical evidence about maintenance of changes after this intervention, we preliminary explored the long term effects of the BPS intervention at 1month and 3-months.
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Materials and Method Participants Participants
were
referred
by
a
rheumatologist
from
the
Rheumatology Unit of the Hospital Arnau of Vilanova. Inclusion criteria established that patients had to be diagnosed with FMS by a rheumatologist according to American College of Rheumatology criteria [42, 43]. Exclusion criteria were suffering from severe mental disorders such as schizophrenia, bipolar disorder, mental retardation, or substance abuse or dependence. Sample size calculations were performed a priori using the statistical program G* Power (version 3.0.10 for Windows). Previous research found effect sizes ranging from medium to small [16, 34]. In the analysis, we found that for an expected small effect size (0.2), with a p